Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age

Официальное название

Early Detection and Prevention of Health Complications in Premature Infants - Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age

Обзор

The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely. The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of children born prematurely. This will minimize the negative impacts on the overall development of the child and the family of the prematurely born children.

Подробное описание

The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely.

The main goal of the project is establishing a methodology for the long-term monitoring of premature infants (in the area of developmental anomalies) and their evaluation at the age of 5 years.

The main objective of this activity is to validate this screening process, which will benefit 210 patients in 2 perinatal and 2 intermediate centers. The child will undergo a comprehensive pediatric examination, including basic vision, speech, and psychomotoric assessments (MABC-2 and IDS-P). If any concerns are identified, the child will be referred to an appropriate specialist. The timeliness of this check-up has significant positive impact on both the patient and their family.

The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22\_005/0002020.

The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.

Вмешательства

• Другое Pediatric check-up
  Eligible children are invited to undergo a comprehensive pediatric evaluation, including vision screening (Plusoptix) and speech and language tests (TEPO - sentence comprehension, TEPRO - vocabulary production). Subsequently, children are referred for psychological (IDS-P), motor (MABC-2), and pulmonary (spirometry) assessments. If any deviations are identified, the child is referred to appropriate specialists (e.g., rehabilitation physician, speech therapist, psychiatrist, ophthalmologist).

Первичные конечные точки

• Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology) [Срок оценки: During study participation (up to 3 days)]
• Proportion of premature infants referred to a specialized center (overall, by detected pathology) [Срок оценки: During study participation (up to 3 days)]

Критерии участия

Критерии включения

• Signed consent for participation in the project and consent for the processing of personal data.
• Children born before 37 weeks of gestation, aged 5 years, growing up in a Czech-speaking environment.
• To ensure valid linkage of all data sources, the children must have been born to parents with Czech citizenship.

Критерии исключения

• Unsigned consent for participation in the project and consent for the processing of personal data.
• Severe psychomotor retardation .
• Severe congenital malformations.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Чехия · 4 центра

• České Budějovice Hospital — České Budějovice
• Hospital Havlíčkův Brod — Havlíčkův Brod
• County Hospital Liberec — Liberec
• General University Hospital — Prague

Идентификаторы

NCT: NCT07391527 · UZIS 2025/3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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